DIPHENHYDRAMINE HYDROCHLORIDE injection, solution

Nazione: Stati Uniti

Lingua: inglese

Fonte: NLM (National Library of Medicine)

Principio attivo:

DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE - UNII:8GTS82S83M)

Commercializzato da:

Fresenius Kabi USA, LLC

INN (Nome Internazionale):

Diphenhydramine Hydrochloride

Composizione:

Diphenhydramine Hydrochloride 50 mg in 1 mL

Via di somministrazione:

INTRAVENOUS

Tipo di ricetta:

PRESCRIPTION DRUG

Indicazioni terapeutiche:

Diphenhydramine hydrochloride in the injectable form is effective in adults and pediatric patients, other than premature infants and neonates, for the following conditions when diphenhydramine hydrochloride in the oral form is impractical. Antihistaminic: For amelioration of allergic reactions to blood or plasma, in anaphylaxis as an adjunct to epinephrine and other standard measures after the acute symptoms have been controlled, and for other uncomplicated allergic conditions of the immediate type when oral therapy is impossible or contraindicated. Motion Sickness: For active treatment of motion sickness. Antiparkinsonism: For use in parkinsonism, when oral therapy is impossible or contraindicated, as follows: parkinsonism in the elderly who are unable to tolerate more potent agents; mild cases of parkinsonism in other age groups, and in other cases of parkinsonism in combination with centrally acting anticholinergic agents. Use in Neonates or Premature Infants: This drug should not be used

Dettagli prodotto:

Diphenhydramine Hydrochloride Injection, USP is a clear and colorless solution available as: 50 mg/mL in a 1 mL prefilled single-use syringe. Available in a carton of twenty-four (24) syringes. NDC 76045-102-10 Store at 20° to 25°C (68° to 77°F) [See USP Controlled Room Temperature.] Protect from freezing and light. Retain in carton until time of use. Do not place syringe on a sterile field.

Stato dell'autorizzazione:

Abbreviated New Drug Application

Scheda tecnica

DIPHENHYDRAMINE HYDROCHLORIDE- DIPHENHYDRAMINE
HYDROCHLORIDE INJECTION, SOLUTION
FRESENIUS KABI USA, LLC
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DIPHENHYDRAMINE HYDROCHLORIDE INJECTION, USP
RX ONLY
DESCRIPTION
Diphenhydramine hydrochloride is an antihistamine drug having the
chemical name 2-
(Diphenylmethoxy)-N,N-dimethylethylamine hydrochloride. It occurs as a
white,
crystalline powder, is freely soluble in water and alcohol and has a
molecular weight of
291.82. The molecular formula is C
H
NO·HCl and the structural formula is as
follows:
Diphenhydramine hydrochloride in the parenteral form is a sterile,
pyrogen-free solution.
Each mL contains a concentration of 50 mg of diphenhydramine
hydrochloride and
water for injection, for intramuscular or intravenous use. The
solution for parenteral use
has been adjusted to a pH between 4 and 6.5 with either sodium
hydroxide or
hydrochloric acid.
CLINICAL PHARMACOLOGY
Diphenhydramine hydrochloride is an antihistamine with anticholinergic
(drying) and
sedative side effects. Antihistamines appear to compete with histamine
for cell receptor
sites on effector cells.
Diphenhydramine hydrochloride in the injectable form has a rapid onset
of action.
Diphenhydramine hydrochloride is widely distributed throughout the
body, including the
CNS. A portion of the drug is excreted unchanged in the urine, while
the rest is
metabolized via the liver. Detailed information on the
pharmacokinetics of
Diphenhydramine Hydrochloride Injection is not available.
INDICATIONS AND USAGE
Diphenhydramine hydrochloride in the injectable form is effective in
adults and pediatric
patients, other than premature infants and neonates, for the following
conditions when
diphenhydramine hydrochloride in the oral form is impractical.
17
21
Antihistaminic: For amelioration of allergic reactions to blood or
plasma, in anaphylaxis as
an adjunct to epinephrine and other standard measures after the acute
symptoms have
been controlled, and for other uncomplicated allergic conditions of
the immediate type
when oral therapy is impossible or contr